Standard Operating Procedure for Preventive Maintenance of Equipment
1) Purpose
The purpose of this SOP is to outline the procedures for performing preventive maintenance on manufacturing equipment to ensure their optimal performance and to prevent unexpected breakdowns.
2) Scope
This SOP applies to all equipment used in the manufacturing of dental pastes, gels, and mouthwashes within the pharmaceutical industry.
3) Responsibilities
The Engineering Department is responsible for performing preventive maintenance. The Production Department is responsible for coordinating the maintenance schedule. The Quality Assurance (QA) Department is responsible for verifying and documenting the maintenance activities.
4) Procedure
4.1 Preparation
4.1.1 Prepare a preventive maintenance schedule based on the equipment manufacturer’s recommendations and production requirements.
4.1.2 Gather all necessary tools, parts, and maintenance manuals.
4.2 Maintenance Activities
4.2.1 Turn off the equipment and disconnect it from power sources.
4.2.2 Inspect the equipment for signs of wear and tear, leaks, or other issues.
4.2.3 Replace worn or damaged parts according to the manufacturer’s specifications.
4.2.4 Lubricate moving parts as per the manufacturer’s guidelines.
4.2.5 Check and tighten any loose connections and fastenings.
4.3 Documentation
4.3.1 Record all maintenance activities in the preventive maintenance log, including parts replaced and any issues identified.
4.3.2 Attach any relevant data, such as calibration certificates or inspection reports, to the maintenance log.
4.4 Approval
4.4.1 Submit the completed maintenance log to the QA Department for review and approval.
4.4.2 Store the approved maintenance log in the equipment maintenance file.
5) Abbreviations, if any
QA – Quality Assurance6) Documents, if any
Preventive Maintenance Schedule
Equipment Maintenance Log
Manufacturer’s Maintenance Manuals
7) Reference, if any
Current Good Manufacturing Practices (cGMP) guidelines
8) SOP Version
Version 1.0
